TY  - JOUR
T1  - THe report by the institute of medicine and postmarketing surveillance
AU  - Klein DF
Y1  - 1999/04/01
N1  - 10.1001/archpsyc.56.4.353
JO  - Archives of General Psychiatry
SP  - 353
EP  - 354
VL  - 56
IS  - 4
N2  - 
The charge to the IOM goes beyond the usual concerns of the FDA about the adequacy of the pivotal clinical trials in a request for drug approval. The FDA further wishes the IOM to comment on the quality and quantity of postmarketing data, confidence in data on the effectiveness and adverse effects of Halcion at different doses and for different durations, and the need for additional studies.

SN  - 0003-990X
M3  - doi: 10.1001/archpsyc.56.4.353
UR  - http://dx.doi.org/10.1001/archpsyc.56.4.353
ER  -